FDA Inspection
Mylan Laboratories LimitedMylan Laboratories Limited – FDA Inspection, Mar 2, 2018
Record Details
This FDA Inspection record concerns Mylan Laboratories Limited, with an inspection on March 2, 2018, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · e9549120-1163-4bc0-88a8-9d2e67a920aa
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1042743
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.25(c)Inadequate number of personnel
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Other FDA inspections of Mylan Laboratories Limited
9| Date | Classification | Office | Project area |
|---|---|---|---|
| July 10, 2026 | Not classified | Office of Inspections and Investigations | |
| February 24, 2023 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 16, 2023 | Not classified | Office of Inspections and Investigations | |
| February 28, 2020 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 13, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Mylan Laboratories Limited
- FDA Inspection 1329374 - 2026-07-10
- FDA Inspection 1204816 - 2023-02-24
- FDA Inspection 1196646 - 2023-01-16
- FDA Inspection 1119165 - 2020-02-28
- FDA Inspection 1089838 - 2019-05-13
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